510(k) · Cleared
ClearedSmith & Nephew Modular Hip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Cleared on Nov 19, 2004 as substantially equivalent to K921111 (Joint Medical Products Corp., 1992) and 6 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1994. 17 later devices descend from it.
- Decided
- Nov 19, 2004
- Review
- 105 days
- Class
- Class II
- Product code
- MEH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K935452 (1994). 12 ancestors in all, the oldest K851422 (1985). 17 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK935452 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Orthopaedics, Inc. · 1994
- 2 generations backK945518 P.F.C. 2 Total Hip System Porous Coated Modular Femoral ComponentJohnson & Johnson Professionals, Inc. · 1996
- 1 generation backK961939 S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Johnson & Johnson Professionals, Inc. · 1996
- This deviceK042127 Smith & Nephew Modular HipSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 14 of its ownK081124 MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 8 of its ownK113789 Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 7 of its ownK151902 REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK052426 Smith & Nephew Modular HipSmith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK121627 Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc. · 2012 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K081124MDF Revision Hip SystemSmith & Nephew, Inc. · 2008 · cites it directly14descendants
- K113789Modular Proximally Fluted Hip StemSmith & Nephew, Inc. · 2012 · 2 generations on8descendants
- K151902REDAPT¿ Revision Femoral SystemSmith & Nephew, Inc. · 2015 · 3 generations on7descendants
- K052426Smith & Nephew Modular HipSmith & Nephew, Inc. · 2005 · cites it directly6descendants
- K121627Smith & Nephew Redapt Revision Femoral SystemSmith & Nephew, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935452 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Orthopaedics, Inc. | 1994 | — |
| −2 | K945518 | P.F.C. 2 Total Hip System Porous Coated Modular Femoral Component | Johnson & Johnson Professionals, Inc. | 1996 | — |
| −1 | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115) | Johnson & Johnson Professionals, Inc. | 1996 | — |
| 0 (this device) | K042127 | Smith & Nephew Modular Hip | Smith & Nephew, Inc. | 2004 | — |
| +1 | K081124 | MDF Revision Hip System | Smith & Nephew, Inc. | 2008 | 2 |
| +2 | K113789 | Modular Proximally Fluted Hip Stem | Smith & Nephew, Inc. | 2012 | 1 |
| +3 | K151902 | REDAPT¿ Revision Femoral System | Smith & Nephew, Inc. | 2015 | — |
| +1 | K052426 | Smith & Nephew Modular Hip | Smith & Nephew, Inc. | 2005 | — |
| +2 | K121627 | Smith & Nephew Redapt Revision Femoral System | Smith & Nephew, Inc. | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MEH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MEH device
- #1 K210581 Actis DuoFix Hip Prosthesis- Collarlessscore 23.9 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921111 | S-Rom Zirconia Cermamic Femoral HeadSummary page 1…ndications for use, design features, operational principles, and material composition to the following predicate devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). (… | 1992 |
| * | K934412 | Coated ZT Proximal SleeveSummary page 1…for use, design features, operational principles, and material composition to the following predicate devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). ( ~~~… | 1994 |
| * | K954935 | S-Rom Femoral Hip Stem - Size 14 X 8Summary page 1…esign features, operational principles, and material composition to the following predicate devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). ( ~~~DEPARTMENT… | 1996 |
| * | K961939 | S-Rom Femoral Hip Stem (Sizes 12 X 06 X 115 and 12 X 07 X 115)Summary page 1…, operational principles, and material composition to the following predicate devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). ( ~~~DEPARTMENT OFBHEALTH &HU… | 1996 |
| * | K963509 | Global Taper Tapered Hip System, GT SpectronSummary page 1…o the following predicate devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). ( ~~~DEPARTMENT OFBHEALTH &HUMAN SERVICES… | 1997 |
| * | K991485 | Synergy Porous Size 8 Hip StemSummary page 1…owing predicate devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). ( ~~~DEPARTMENT OFBHEALTH &HUMAN SERVICES Public Hea… | 1999 |
| * | K002996 | Synergy HA Coated Porous Femoral StemsSummary page 1…e devices - Joint Medical Products S-ROM Total Hip System (K921111, K(934412, K(954935, and K(961939) and the Smith & Nephew Synergy Hip System K1963509, K(991485, and K(002996). ( ~~~DEPARTMENT OFBHEALTH &HUMAN SERVICES Public Health Service… | 2000 |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K081124 (Smith & Nephew, Inc., 2008) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K921111.
How does its category compare?
All MEH devicesMEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEH
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MEH
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEH
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MEH
470in 2025
MAUDE reports naming product code MEH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 25 |
| 2008 | 6 | 79 | 80 | 261 |
| 2009 | 6 | 65 | 51 | 539 |
| 2010 | 5 | 226 | 16 | 462 |
| 2011 | 5 | 95 | 4 | 419 |
| 2012 | 6 | 131 | 3 | 1,606 |
| 2013 | 1 | — | 0 | 1,295 |
| 2014 | 0 | — | 1 | 1,196 |
| 2015 | 2 | — | 1 | 490 |
| 2016 | 6 | 163 | 4 | 347 |
| 2017 | 3 | 209 | 1 | 383 |
| 2018 | 2 | — | 3 | 337 |
| 2019 | 1 | — | 0 | 335 |
| 2020 | 3 | 131 | 1 | 338 |
| 2021 | 3 | 83 | 0 | 372 |
| 2022 | 3 | 150 | 0 | 316 |
| 2023 | 2 | — | 0 | 334 |
| 2024 | 6 | 91 | 0 | 354 |
| 2025 | 5 | 87 | 1 | 470 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip…
Read the full statement (121 words)
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042127 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042127: Smith & Nephew Modular Hip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042127
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026